David Doherty Email & Phone Number | * Immunoassay development and validation, and analysis of pharmacokinetic samples under GxP regulations - Managing multiple projects and producing high quality data under high pressure situations. * Bioanalytical Principal Investigator of validation and analysis of GLP studies. * Subject matter expert of laboratory automation for department, primarily on the Tecan Freedom EVO - Creation, development, and implementation of automation scripts/methods for all laboratory users, leading to more efficient process flow and higher precision assays. * Subject matter expert of GxP and non-GxP electronic laboratory notebook system - Development, training, and implementation of GxP and non-GxP IDBS E-Workbook ELN system. Authored department SOP and manual on use of ELN. Developed ELN experiment templates for efficient streamlining across sites. Designed process workflow for GxP experiments, including planning experiments, QC review process, and audit trail/data integrity review process. Piloted initial validation and GLP studies using ELN, removing almost all need for paper-based documentation. * Primary contact for ordering supplies, reagents, and matrix for all lab users - Ensures buffers, reagents, and supplies are available for regulated and non-regulated laboratory work. Also includes Instrument maintenance and troubleshooting. * Software and instrument validation for site and department - including writing, reviewing, and executing test scripts for validation of Tecan Freedom EVO instrument and software, Hamilton Microlab STAR instrument and software, Softmax Pro software, Watson LIMS, StarLIMS. * Responsible Scientist for assay transfer to CRO - Re-development of clinical assay and working with Test Site Coordinator to efficiently transfer highly reproducible analytical method. Includes review of CRO documentation and data, troubleshooting of assay issues, and optimization of automation scripts and equipment.

David Doherty

* Immunoassay development and validation, and analysis of pharmacokinetic samples under GxP regulati...
Newbury Park, Newbury Park, United States

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David Doherty’s Email ddoherty@nektar.com

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David Doherty’s Location Newbury Park, Newbury Park, United States

David Doherty’s Current Industry Exelixis

David Doherty’s Prior Industry Nektar Therapeutics | Amgen

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Work Experience

Exelixis

Senior Bioanalytical Scientist II

2022-05-01 00:00:00 - Present

Nektar Therapeutics

Senior Scientist

2019-02-01 00:00:00 - 2022-05-01 00:00:00

Amgen

Scientist

2004-06-01 00:00:00 - 2019-01-01 00:00:00

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FAQ About David Doherty

David Doherty is located at
Newbury Park, Newbury Park, United States

David Doherty is a * Immunoassay development and validation, and analysis of pharmacokinetic samples under GxP regulations - Managing multiple projects and producing high quality data under high pressure situations. * Bioanalytical Principal Investigator of validation and analysis of GLP studies. * Subject matter expert of laboratory automation for department, primarily on the Tecan Freedom EVO - Creation, development, and implementation of automation scripts/methods for all laboratory users, leading to more efficient process flow and higher precision assays. * Subject matter expert of GxP and non-GxP electronic laboratory notebook system - Development, training, and implementation of GxP and non-GxP IDBS E-Workbook ELN system. Authored department SOP and manual on use of ELN. Developed ELN experiment templates for efficient streamlining across sites. Designed process workflow for GxP experiments, including planning experiments, QC review process, and audit trail/data integrity review process. Piloted initial validation and GLP studies using ELN, removing almost all need for paper-based documentation. * Primary contact for ordering supplies, reagents, and matrix for all lab users - Ensures buffers, reagents, and supplies are available for regulated and non-regulated laboratory work. Also includes Instrument maintenance and troubleshooting. * Software and instrument validation for site and department - including writing, reviewing, and executing test scripts for validation of Tecan Freedom EVO instrument and software, Hamilton Microlab STAR instrument and software, Softmax Pro software, Watson LIMS, StarLIMS. * Responsible Scientist for assay transfer to CRO - Re-development of clinical assay and working with Test Site Coordinator to efficiently transfer highly reproducible analytical method. Includes review of CRO documentation and data, troubleshooting of assay issues, and optimization of automation scripts and equipment.